Optimi Health Announces First PTSD Patients Treated with MDMA Capsules in Australia
Optimi Health announces successful treatment of first PTSD patients in Australia using its GMP-certified MDMA capsules under the Authorised Prescriber Scheme. Following high demand and full allocation of initial 160 doses in under eight weeks, an additional 700 doses have been ordered. Patient Reported Outcomes are being collected through Australian National University's patient registry, creating valuable data on MDMA treatment effectiveness. The company's Drug Establishment Licence from Health Canada enables manufacturing and export of GMP MDMA capsules to regulated markets globally. Despite FDA delays in the U.S., Optimi continues prioritizing treatment access in Australia, where Americans can travel to receive therapy.
Optimi Health annuncia il trattamento di successo dei primi pazienti con PTSD in Australia utilizzando le sue capsule di MDMA certificate GMP nell'ambito del Piano di Prescrittore Autorizzato. A seguito di un'alta domanda e piena assegnazione delle prime 160 dosi in meno di otto settimane, sono state ordinate ulteriori 700 dosi. I risultati riportati dai pazienti vengono raccolti attraverso il registro dei pazienti dell'Università Nazionale Austriaca, creando dati preziosi sull'efficacia del trattamento con MDMA. La licenza di stabilimento per farmaci dell'azienda da parte di Health Canada consente la produzione e l'esportazione di capsule di MDMA GMP ai mercati regolamentati a livello globale. Nonostante i ritardi della FDA negli Stati Uniti, Optimi continua a dare priorità all'accesso alla terapia in Australia, dove gli americani possono recarsi per ricevere trattamento.
Optimi Health anuncia el tratamiento exitoso de los primeros pacientes con PTSD en Australia utilizando sus cápsulas de MDMA certificadas como GMP bajo el Esquema de Prescriptor Autorizado. Tras una alta demanda y la asignación completa de las 160 dosis iniciales en menos de ocho semanas, se han solicitado 700 dosis adicionales. Los Resultados Reportados por los Pacientes se están recopilando a través del registro de pacientes de la Universidad Nacional de Australia, creando datos valiosos sobre la eficacia del tratamiento con MDMA. La Licencia de Establecimiento de Drogas de la empresa otorgada por Health Canada permite la fabricación y exportación de cápsulas de MDMA GMP a mercados regulados a nivel mundial. A pesar de los retrasos de la FDA en EE.UU., Optimi sigue priorizando el acceso al tratamiento en Australia, donde los estadounidenses pueden viajar para recibir terapia.
옵티미 헬스는 승인된 처방자 제도에 따라 GMP 인증을 받은 MDMA 캡슐을 사용하여 호주에서 PTSD 환자 첫 치료의 성공을 발표했습니다. 초기 160개의 복용량이 8주도 안 되어 모두 할당된 후, 추가로 700개의 복용량이 주문되었습니다. 환자 신고 결과는 호주 국립대학교의 환자 등록부를 통해 수집되어 MDMA 치료의 효과에 대한 귀중한 데이터를 생성하고 있습니다. 회사는 캐나다 보건부의 약물 제조 허가를 통해 GMP MDMA 캡슐의 제조 및 수출을 전 세계 규제 시장에 허용하고 있습니다. 미국에서의 FDA 지연에도 불구하고, 옵티미는 미국인이 치료를 받을 수 있는 호주에서 치료 접근을 우선시하고 있습니다.
Optimi Health annonce le traitement réussi des premiers patients PTSD en Australie utilisant ses capsules de MDMA certifiées GMP dans le cadre du Schéma de Prescripteur Autorisé. Suite à une forte demande et à l’allocation complète des 160 doses initiales en moins de huit semaines, 700 doses supplémentaires ont été commandées. Les résultats rapportés par les patients sont recueillis par le registre des patients de l’Université Nationale Australienne, créant des données précieuses sur l’efficacité du traitement par MDMA. La Licence de Fabrication de Médicaments de l’entreprise délivrée par Santé Canada permet la fabrication et l’exportation de capsules de MDMA GMP vers des marchés réglementés à l’échelle mondiale. Malgré les retards de la FDA aux États-Unis, Optimi continue de prioriser l’accès au traitement en Australie, où les Américains peuvent voyager pour recevoir une thérapie.
Optimi Health kündigt die erfolgreiche Behandlung der ersten PTSD-Patienten in Australien mit seinen GMP-zertifizierten MDMA-Kapseln im Rahmen des autorisierten Verschreibersystems an. Nach einer hohen Nachfrage und vollständiger Zuteilung der ersten 160 Dosen in weniger als acht Wochen wurden zusätzlich 700 Dosen bestellt. Die von den Patienten berichteten Ergebnisse werden durch das Patientenregister der Australian National University erfasst, was wertvolle Daten zur Wirksamkeit der MDMA-Behandlung liefert. Die Arzneimittelherstellungslizenz des Unternehmens von Health Canada ermöglicht die Herstellung und den Export von GMP MDMA-Kapseln in regulierte Märkte weltweit. Trotz der Verzögerungen der FDA in den USA priorisiert Optimi weiterhin den Therapiezugang in Australien, wo Amerikaner reisen können, um eine Behandlung zu erhalten.
- First successful commercial treatment of PTSD patients with company's MDMA capsules
- Strong market demand demonstrated by full allocation of initial 160 doses in 8 weeks
- Additional order of 700 doses received
- Real-world patient data collection through Australian National University
- Established export capability through Health Canada Drug Establishment Licence
- FDA delay in U.S. market approval affecting potential market expansion
- to Australian market currently
Additional 700 Doses Ordered by Mind Medicine Australia as Demand Surges
Vancouver, British Columbia--(Newsfile Corp. - October 23, 2024) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Health Canada-licensed manufacturer of psychedelic pharmaceuticals specializing in botanical psilocybin and MDMA, is proud to announce that the first group of patients with post-traumatic stress disorder (PTSD) in Australia has successfully received treatment with its GMP-certified MDMA capsules under the Authorised Prescriber Scheme. In response to growing demand, the Company has received an additional order for 700 doses after its initial shipment of 160 doses was fully allocated in under eight weeks.
Key Highlights:
- First Patient Dosing: Patients in Australia are being treated with Optimi's GMP-certified MDMA capsules for PTSD, positioning Optimi as one of the few companies with in-market products actively treating real patients.
- Additional Orders: An additional 700 doses of MDMA capsules have been ordered to meet demand after the initial 160 doses were fully allocated in less than eight weeks.
- Real World Data: The Patient Reported Outcomes (PROs) being gathered through the patient registry at Australian National University will provide data on the effectiveness of MDMA treatments across a diverse range of Australian patients. The data collected from thousands of patients using Optimi's MDMA will be one of the most comprehensive and valuable data sets in the history of psychedelic-assisted therapies.
"This is a major advancement for Optimi and our investors," said Dane Stevens, CMO and CEO of Optimi. "We're not just talking about potential-we're actively treating patients today. The fact that our first shipment is fully allocated with an additional order placed proves the need for MDMA-assisted therapy is real, and Optimi is meeting that demand."
Stevens added, "Despite the recent setback in the U.S. with the FDA delaying the approval of MDMA-assisted therapy, we believe the progress being made in Australia will accelerate the push to treat Americans suffering from PTSD. Right now, Americans can actually travel to Australia to receive these life-changing treatments through the Authorised Prescriber Scheme. While the situation in the U.S. continues to unfold, we'll continue to prioritize doses to patients in Australia today."
Optimi's close collaboration with Mind Medicine Australia-a leading non-profit focused on expanding access to psychedelic-assisted therapies-has been instrumental in bringing these treatments to market. Mind Medicine Australia advocates for the safe integration of psychedelics into mental health treatments and has been a key partner in connecting Optimi's MDMA with Australian healthcare providers.
Peter Hunt, Chairman of Mind Medicine Australia, commented, "The partnership with Optimi is delivering real solutions for patients today. The successful dosing of the first patients in Australia is just the beginning. We're excited about the future impact this collaboration will have on mental health treatments globally."
Global Context:
PTSD affects approximately
The MDMA capsules were exported under Optimi's recently awarded Drug Establishment Licence (DEL) from Health Canada, which allows the Company to manufacture and export GMP MDMA capsules to regulated markets globally. With this DEL, Optimi's MDMA capsules can be prescribed by healthcare professionals in regulated markets for the treatment of PTSD.
On behalf of the Board of Directors,
OPTIMI HEALTH CORP.
JJ Wilson, Chair of the Board
For more information, please contact the Company at:
Telephone: (778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions, or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct, and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/227511
FAQ
How many MDMA doses has Optimi Health (OPTHF) shipped to Australia in 2024?
Where are Optimi Health's (OPTHF) MDMA capsules being used for PTSD treatment in 2024?
Can U.S. patients access Optimi Health's (OPTHF) MDMA treatment in 2024?
